The present prospective study investigated for the first time the efficacy and safety of TACO2L a novel method for the treatment of patients with mild SUI. The most salient finding of the present study is that the treatment with TACO2L significantly improved ICIQ-UI SF scores and 1-h pad weight test results, and the improvements were maintained during the 36 months of observation without any need for further reintervention. The results were confirmed by crucial histological changes indicating trophic restoration of the vagina, that is responsible for important extrinsic and intrinsic mechanisms involved in urinary continence. These observations suggest that TACO2L is an effective and safe procedure for the treatment of mild SUI.
Currently, there are many initial nonsurgical therapies for patients with SUI, e.g. behavioral therapy, pelvic floor muscle exercises, electric stimulation, vaginal cones, occlusive and intravaginal devices, and pharmacological treatment. However, these strategies require the patient to show patience, motivation and time commitment, and to undergo training. Women are unlikely to comply with a strict program of behavior modification and regular pelvic floor exercises.
Thus, although surgery is more invasive and is burdensome in terms of complications and recovery time, it still remains a more attractive and useful option for the treatment of SUI. Therefore, other noninvasive methods are still urgently required.
Previous studies have shown molecular changes and collagen synthesis in the atrophic vagina after fractional CO2 treatment [5, 8]. The biostimulative effect of TACO2L restores most vaginal functions, including secretion, absorption, elasticity and lubrication, and the thickness of the vaginal epithelium . It has been proposed that the production of elastic fibers and stimulation of neocollagenesis, that leads to increased thickness of the vaginal epithelium may be related to the restoration of urethral coaptation mechanisms involved in the physiopathology of SUI [8, 9]. Furthermore, recent pilot studies have shown remarkable improvement in SUI after laser energy treatment including recovery of the submucosal blood vessel plexus and an increase in periurethral muscle tone that is related to the urethral closure pressure mechanism [8, 9].
Radiofrequency ablation is used in the laparoscopic and transurethral treatment of SUI [10,11,12,13,14]. Fistonic et al. performed the pilot study in 39 patients with mild-to-moderate SUI with or without prolapse and revealed that nonablative fractional laser treatment with the IncontiLase™ system was efficient, safe and comfortable . However, Fistonic et al. used only the ICIQ-UI SF and the Q-tip test to assess the efficacy of the method. Tien et al. demonstrated the feasibility of the IncontiLase system for the treatment of mild SUI with a follow-up of 6 months but found no effect in patients with a pad weight >10 g . They found that treatment with the IncontiLase system improves lower urinary tract symptoms, quality of life and sexual function of both partners . However, the short follow-up, the lack of a control group and the small study population limits the value of the study results.
TACO2L therapy seems to be a promising alternative for the treatment of SUI and other symptoms related to GSM. However, there may be safety concerns among the scientific community. Therefore, we focused on investigating a new device that works in different pulse shape modes with computer-controlled fractional emission. The fractional CO2 laser penetrates, and therefore interacts with, the vaginal epithelium to a depth of not more than 0.6 mm. Therefore thermal diffusion to structures around the vagina such as the rectum, bladder and peritoneal cavity is not possible. Our study demonstrated that an adequate amount of heat is delivered to the deep vaginal epithelium and urogenital structures to generate histologically confirmed structural changes that seem to be related to vaginal trophic intrinsic and extrinsic continence mechanisms of the urethra. This treatment strategy should not be used in patients with advanced stage pelvic organ prolapse which is managed by site-specific repair with or without extirpative surgery. Furthermore, moderate and severe urinary incontinence should be treated by placement of a midurethral sling, which remains the first-line surgical procedure with a long-term cure rate of 77–85% [15, 16].
Thus, TACO2L should not replace invasive procedures in advanced stage urinary incontinence if a first-line therapy is ineffective. In this study we showed for the first time the long-term efficacy of this novel treatment strategy that may have an impact on future guidelines for the management of SUI. Of note, the improvements were maintained for up to 36 months without the need for any further intervention. Although, there was no difference in the 1-h pad test results between the follow-up time points, a significant increase in ICIQ-UI SF score was documented after 12 months (Figs. 1 and 2). This result indicates that sequential TACO2L may be needed following the baseline procedure.
TACO2L seems to be an attractive alternative method and the best option for patients with GSM and mild SUI, who either do not have a surgical indication and/or have contraindications to surgery or do not wish to undergo an invasive procedure. The lack of significant adverse effects, its noninvasive nature and significant improvement in ICIQ-UI SF scores and pad weight test results over a long follow-up, supported by histological analysis, confirm TACO2L as a beneficial treatment strategy that allows the need surgery to be avoided or postponed.
Limitations of the study
This was a prospective, nonrandomized study of an observational nature with no control group. Since all patients enrolled were relatively young (45–65 years), the results of this particular study cannot be translated into older populations.
Our results suggest that TACO2L is an efficient and safe novel strategy for the treatment of mild SUI. The TACO2L procedure should not only be applied in the field of esthetic gynecology as its primary goal is to restore intrinsic and extrinsic continence mechanisms related to the trophism of the vaginal epithelium and to improve long-term urinary incontinence related to GSM. Further investigation to confirm the long-term effects of TACO2L is still warranted.